The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are: * Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate? * Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer. Participants will: * Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3 * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan
RECRUITINGOverall response rate of the treatment
Overall response rate = complete response (CR) rate + partial response (PR) rate.
Time frame: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Duration of response (DOR)
Defined as the time from CR or PR to the time of disease progression or death.
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Esophageal perforation rate
Detected by bronchoscopy or CT scan.
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.
Adverse events of treatment
Any adverse events of chemotherapy or CCRT.
Time frame: During treatment (up to 24 weeks)
Progression-free survival
Defined as the time from diagnosis to the time of disease progression or death.
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Overall survival time
Defined as the time from diagnosis to the time of death.
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
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